InfertilityPhase 4NCT02436226
Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS
A Phase 4 study testing Clomiphene citrate and Human chorionic gonadotropin (HCG) and Clomiphene citrate in people with Infertility and Polycystic Ovarian Syndrome, run by Mohamed Sayed Abdelhafez at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the effect of administration of low dose of human chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation in infertile women having CC resistant polycystic ovarian syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility, Polycystic Ovarian Syndrome
- What is being tested?
- Clomiphene citrate and Human chorionic gonadotropin (HCG) and Clomiphene citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Jan 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile lean women with PCOS as defined by the Rotterdam criteria.
- CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).
Who cannot join
- Age < 20 or > 35 years.
- Presence of any infertility factor other than anovulatory PCOS.
- Previous history of ovarian surgery or surgical removal of one ovary.
- Previous exposure to cytotoxic drugs or pelvic irradiation.
- Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
- Metabolic or hormonal abnormalities.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, 35111
About this study
Official title: Use of Low Dose of Human Chorionic Gonadotropin During Ovulation Induction With Clomiphene Citrate in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
The purpose of this study is to evaluate the effect of administration of low dose of human chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation in infertile women having CC resistant polycystic ovarian syndrome (PCOS).
Read the detailed description
Women will be randomly divided into two groups; CC-HCG group and CC group. Women in the CC-HCG group will receive CC (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle). Women in the CC group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of HCG and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle
- Conditions
- Infertility, Polycystic Ovarian Syndrome
- Being tested
- Clomiphene citrate and Human chorionic gonadotropin (HCG), Clomiphene citrate
- Keywords
- PCOS, Clomiphene citrate resistant, HCG
- Medical subject headings
- Infertility, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene citrate and Human chorionic gonadotropin (HCG)Drug
Also called Clomid and Choriomon
Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle)
Clomiphene citrateDrug
Also called Clomid
Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle)
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene citrate-HCG group | Active comparator | Women will receive clomiphene citrate and human chorionic gonadotropin (HCG) Receives: Drug: Clomiphene citrate and Human chorionic gonadotropin (HCG) |
| Clomiphene citrate group | Active comparator | Women will receive clomiphene citrate alone Receives: Drug: Clomiphene citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation rate
Number of ovulatory cycles divided by the number of stimulation cycles
Measured: 3 months
Secondary outcomes (4)
Number of ovarian follicles ≥ 18 mm on day of triggering of oocyte maturation
Number of ovarian follicles ≥ 18 mm by TVS on day of triggering of oocyte maturation
Measured: 3 months
Endometrial thickness on day of triggering of oocyte maturation
Endometrial thickness by Transvaginal sonography (TVS) scan on day of triggering of oocyte maturation
Measured: 3 months
Clinical pregnancy rate
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women
Measured: 6-8 weeks gestational age
Incidence of early ovarian hyperstimulation syndrome (OHSS)
Incidence of OHSS within 9 days of final triggering of oocyte maturation
Measured: Within 9 days of final triggering of oocyte maturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMar 2016
- Primary completionJan 2023
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Sayed Abdelhafez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Sayed Abdelhafez, Mansoura University
- Investigators
- Mahmoud Thabet, MD, Principal investigator, Mansoura UniversityKhaled S Ismael, MD, Study director, Mansoura UniversityAhmed Ragab, MD, Study director, Mansoura UniversityMaged R Elshamy, MD, Study director, Mansoura UniversityMohamed A Elnegery, MD, Study director, Mansoura UniversityHamed Youssef, MD, Study director, Mansoura UniversityMahmoud M Abdel-razik, MD, Study director, Mansoura UniversityMohamed S Abdelhafez, MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436226
- Sponsor's protocol ID
- MT1
- Status last verified
- Oct 2023
- First submitted
- 2 May 2015
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Thabet M, Abdelhafez MS, Elshamy MR, Albahlol IA, Fayala E, Wageeh A, El-Zayadi AA, Bahgat NA, Mohammed SM, Mohamed AA, Awad MM, El-Menayyer A, El-Sherbiny M, Elsherbini DMA, Albarakati RG, Alshaikh ABA, Edris FE, Bushaqer NJ, Salama YGM, Abdel-Razik MM. Competence of Combined Low Dose of Human Chorionic Gonadotropin (HCG) and Clomiphene Citrate (CC) Versus Continued CC during Ovulation Induction in Women with CC-Resistant Polycystic Ovarian Syndrome: A Randomized Controlled Trial. Medicina (Kaunas). 2024 Aug 12;60(8):1300. doi: 10.3390/medicina60081300.
PubMed 39202581
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Low Dose of Human Chorionic Gonadotropin During Ovulation Induction With Clomiphene Citrate in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT02436226
- Acronym / sponsor ID
- MT1
- Conditions
- Infertility, Polycystic Ovarian Syndrome
- Keywords
- PCOS, Clomiphene citrate resistant, HCG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Mohamed Sayed AbdelhafezUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2023 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of administration of low dose of human chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation in infertile women having CC resistant polycystic ovarian syndrome (PCOS).
Detailed description
Women will be randomly divided into two groups; CC-HCG group and CC group. Women in the CC-HCG group will receive CC (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle). Women in the CC group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of HCG and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomiphene citrate-HCG group | Active comparator | Drug: Clomiphene citrate and Human chorionic gonadotropin (HCG)Women will receive clomiphene citrate and human chorionic gonadotropin (HCG) |
| Clomiphene citrate group | Active comparator | Drug: Clomiphene citrateWomen will receive clomiphene citrate alone |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Infertile lean women with PCOS as defined by the Rotterdam criteria.
- CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).
Key exclusion criteria (6 listed)
- Age < 20 or > 35 years.
- Presence of any infertility factor other than anovulatory PCOS.
- Previous history of ovarian surgery or surgical removal of one ovary.
- Previous exposure to cytotoxic drugs or pelvic irradiation.
- Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clomiphene citrate and Human chorionic gonadotropin (HCG)Also: Clomid and ChoriomonWomen will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle) | Drug | Clomiphene citrate-HCG group |
| Clomiphene citrateAlso: ClomidWomen will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) | Drug | Clomiphene citrate group |
Primary outcome
Ovulation rate
Time frame: 3 months
Number of ovulatory cycles divided by the number of stimulation cycles
4 secondary outcomes
Number of ovarian follicles ≥ 18 mm on day of triggering of oocyte maturation
Time frame: 3 months
Endometrial thickness on day of triggering of oocyte maturation
Time frame: 3 months
Clinical pregnancy rate
Time frame: 6-8 weeks gestational age
Incidence of early ovarian hyperstimulation syndrome (OHSS)
Time frame: Within 9 days of final triggering of oocyte maturation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 39202581Thabet M, Abdelhafez MS, Elshamy MR, Albahlol IA, Fayala E, Wageeh A, El-Zayadi AA, Bahgat NA, Mohammed SM, Mohamed AA, Awad MM, El-Menayyer A, El-Sherbiny M, Elsherbini DMA, Albarakati RG, Alshaikh ABA, Edris FE, Bushaqer NJ, Salama YGM, Abdel-Razik MM. Competence of Combined Low Dose of Human Chorionic Gonadotropin (HCG) and Clomiphene Citrate (CC) Versus Continued CC during Ovulation Induction in Women with CC-Resistant Polycystic Ovarian Syndrome: A Randomized Controlled Trial. Medicina (Kaunas). 2024 Aug 12;60(8):1300. doi: 10.3390/medicina60081300.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Thabet, MD principal investigator
Mansoura University
Khaled S Ismael, MD study director
Mansoura University
Ahmed Ragab, MD study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clomiphene citrate and Human chorionic gonadotropin (HCG) and Clomiphene citrate in people with Infertility and Polycystic Ovarian Syndrome, run by Mohamed Sayed Abdelhafez at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02436226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.